Kornimate/medical-research-clean huggingface dataset:
evaluation of the effectiveness of eliquis ® (apixaban) risk minimization tools in european economic area (eea) countries

Conditions: Stroke, Systemic Embolism, VTEt and VTEp

Summary: the main purpose is to evaluate the effectiveness of the eliquis® (apixaban) prescriber guide and patient alert card in terms knowledge of the important identified risk of bleeding associated with eliquis treatment communicated by the rm tools.

observational model, other- this is a non-interventional, cross-sectional study in the eea involving representative samples of hcps who treat patients with eliquis, as well as patients treated with eliquis. this study will be facilitated via web-based surveys used to evaluate the effectiveness of the eliquis prescribe guide and patient alert card as risk management tools. enrollment: 384 health care professions (hcps) and 192 patients treatment of deep vein thrombosis (dvt) and pulmonary embolism (pe) and prevention of recurrent dvt and pe in adults (vtet) prevention of vte in adult patients knee replacement surgery (vtep)

Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * hcp must have been involved in the treatment of at least one patient with eliquis for any approved indication * patients must have taken eliquis for any approved indication
blood tuberculosis dna levels to monitor tuberculosis treatment

Conditions: Mycobacterium Tuberculosis; Tuberculosis, Pulmonary; Tuberculosis, Extra-Pulmonary

Summary: tuberculosis (tb) is a leading infectious cause of death worldwide. current strategies for monitoring tb treatment response are culture dependent and insensitive. new methods of assessing treatment response in vivo could inform new drug development and other treatment strategies. cell-free dna (cfdna) - small circulating fragments of dna - is widely used in maternofetal medicine and oncology for diagnosis and assessment of treatment response. this study aims to investigate whether pathogen derived mycobacterium tuberculosis-specific cfdna (mtb-cfdna) can be used to monitor tb treatment response. this feasibility study will take place at mae ramat tb center in thailand and includes two study groups: 1. assay development and validation 2. longitudinal assessment of mtb-cfdna levels

this study is funded by the wellcome trust; grant reference number: 223099/z/21/z

Eligibility criteria:
inclusion criteria: participants with a new diagnosis of tuberculosis * aged ≥ 18 years old * newly microbiologically confirmed (culture or nucleic acid amplification test) diagnosis of mycobacterium tuberculosis (mtb.) infection (of any site) * has not yet commenced antituberculosis therapy * able to understand study procedures and requirements and is able to give informed consent for healthy volunteers: * aged ≥ 18 years old * healthy as judged by a responsible physician * able to understand study procedures and requirements and is able to give informed consent exclusion criteria: participants with a new diagnosis of tuberculosis * exposure to antituberculosis treatment in the last 8 weeks (or mycobacterium tuberculosis (mtb.) active fluoroquinolone) * known history of underlying malignancy * pregnancy * transfusion dependent anaemia for healthy volunteers: * history of tuberculosis infection or latent tuberculosis infection * household, or other close contact, of a person living with tuberculosis disease * chest radiograph (cxr) changes suggestive of pulmonary tuberculosis * presence of symptoms which would otherwise indicate screening for tuberculosis (cough \> 2 weeks duration, fever, weight loss, night sweats) * other major medical comorbidity * pregnancy * known malignancy

Keywords: cfdna
low intensity versus self-guided internet-delivered psychotherapy for major depression

Conditions: Depression

Summary: background: major depression will become the second most important cause of disability in 2020. computerised cognitive-behaviour therapy could be an efficacious and cost-effective option for its treatment. no studies on cost-effectiveness of low intensity vs self-guided psychotherapy have been carried out. aim: to assess the efficacy of low intensity vs self-guided psychotherapy for major depression in the spanish health system. methods: the study is made up of 3 phases: 1.- development of a computerised cognitive-behaviour therapy for depression tailored to spanish health system. 2.- multicenter controlled, randomized study: a sample (n=450 patients) with mild/moderate depression recruited in primary care. they should have internet availability at home, not receive any previous psychological treatment, and not suffer from any other severe somatic or psychological disorder. they will be allocated to one of 3 treatments: a) low intensity internet-delivered psychotherapy + improved treatment as usual (itau) by gp, b) self-guided internet-delivered psychotherapy + itau or c) itau. patients will be diagnosed with mini psychiatric interview. main outcome variable will be beck depression inventory. it will be also administered euroqol 5d (quality of life) and client service receipt inventory (consume of health and social services). patients will be assessed at baseline, 3 and 12 months. an intention to treat and a per protocol analysis will be performed.


Eligibility criteria:
inclusion criteria: * diagnosis of major depression. it will be carried out with mini international neuropsychiatric interview + scoring of moderate or mild depression using beck depression inventory ii. cut-off point for this questionnaire is: 0-13: minimal depression; 14-19: mild depression; 20-28: moderate depression; 29-63: severe depression \[34, 35\]. * aged 18-65 years * able to understand and read spanish * moderate or mild major depression * duration of symptoms longer than 2 weeks * access to internet at home and having an email address. exclusion criteria: * any psychological treatment during last year * severe psychiatric disorder in axis i (alcohol/substances abuse or dependence, psychotic disorders or dementia)patients with severe depression (indicated by a beck-ii score of 29 or higher) who will be advised to consult their gp receiving pharmacological treatment with antidepressants is not an exclusion criteria meanwhile, during the study period, treatment will not be modified or increased (decrease of pharmacological treatment is accepted).

Keywords: depression computer-delivered psychotherapy randomized-controlled trial
omega 3 fatty acids in the treatment of children with autism spectrum disorders

Conditions: Autism

Summary: published studies on omega 3 fatty acids in the treatment of bipolar disorder and schizophrenia have shown reductions in time to recurrence, a decrease in the positive and negative symptoms of schizophrenia, and improvements in clinical global impression scale, young mania rating scale, and ham-d scores. the following are the hypotheses: * omega 3 fatty acids will be superior to placebo in the acute treatment of global autism. * omega 3 fatty acids will be superior to placebo in improving aggression and irritability associated with autism. * omega 3 fatty acids will be superior to placebo in improving functional ability.

this study is an innovative treatment approach to autism. it adapts a promising adjunct therapy for bipolar disorder and schizophrenia to a new population, that of children and adolescents with autism. it will analyze the possible relationship between dosage of omega 3 fatty acids and treatment outcomes. finally, it will attempt to identify which specific subgroups of subjects will respond to this intervention, which components and associated features are most responsive and whether this impacts subjects' quality of life. the data generated by this study is intended to support the rationale for a full scale, large multi-site clinical trial.

Eligibility criteria:
inclusion criteria: * child/teen has autism. * he/she is between five and seventeen years of age. * he/she is not in the hospital. * he/she has a parent or legal guardian who is willing and able to sign the informed consent. exclusion criteria: * child/teen has been diagnosed with a psychotic disorder (such as schizophrenia) or a mood disorder, including depression or bipolar disorder (manic depression). * he/she has caused visible harm to him/herself or is at risk for suicide. * he/she has an active seizure disorder or epilepsy (seizures within the past year). * he/she has an unstable medical illness, including heart disease. * he/she has experienced brain injury. * he/she has a history of diabetes. * he/she has a history of prior treatment with omega 3 fatty acids. * he/she lives in a far away area and/or does not have regular access to transportation to the clinical facility. * a pregnant female or unwilling to use acceptable contraception if sexually active.

Keywords: aggression irritability global severity
a study to evaluate the safety of a single intravenous (iv) dose of orbactiv (oritavancin) in participants on chronic warfarin therapy being treated for acute bacterial skin and skin structure infection (absssi)

Conditions: Acute Bacterial Skin and Skin Structure Infection

Summary: this was a phase 4, multicenter, open-label safety study of a single 1200 milligrams (mg) iv infusion of oritavancin in adult participants on chronic warfarin with acute bacterial skin and skin structure infection (absssi) suspected or proven to be caused by gram-positive pathogens. an additional group of participants with absssi, who were not on concomitant warfarin therapy, were also enrolled to obtain additional information following a single dose of oritavancin administration.


Eligibility criteria:
inclusion criteria: * diagnosis of absssi (wound infection, cellulitis/erysipelas, or cutaneous abscess) suspected or confirmed to be caused by a gram-positive pathogen requiring iv therapy * must be currently being treated with chronic warfarin therapy\* \*participants in the non-warfarin group are not required to be on chronic warfarin therapy. exclusion criteria: * known or suspected bacteremia, sepsis or refractory shock * participants who are likely to need treatment with iv heparin within 48 hours * significant or life-threatening condition * women who are pregnant or nursing * receiving chronic systemic immunosuppressive therapy such as chemotherapy or prednisone * cd4 count \<200 cells/mm\^3 in participants with known human immunodeficiency virus or acquired immune deficiency syndrome * neutropenia

Keywords: skin infection
tubal flushing using water soluble media for unexplained infertility

Conditions: Infertility

Summary: 300 women with unexplained infertility will be randomly divided into 2 equal groups: group 1 will be offered tubal flushing with water soluble media through hysterosalpingography (hsg) and group 2 will receive no intervention

the potential therapeutic effect of diagnostic tubal patency testing has been debated for over 40 years. tubal flushing might involve water- or oil-soluble media. current practice usually involves water-soluble media when tubal flushing is performed at laparoscopy. a systematic review showed a significant increase in pregnancy rates with tubal flushing using oil-soluble contrast media when compared with no treatment. tubal flushing with oil soluble contrast media was associated with an increase in the odds of live birth when compared with tubal flushing with water-soluble media. there were no trials assessing tubal flushing with water-soluble media versus no treatment. the potential consequences of extravasations of oil-soluble contrast media into the pelvic cavity and fallopian tubes may be associated with anaphylaxis and lipogranuloma. it has been reported that further randomised controlled trials are needed to evaluate the potentially therapeutic effects of tubal flushing with water-soluble media. all patients attending the subfertility clinic with infertility, normal semen analysis and evidence of ovulation will be invited to participate in the study. the nature of the study and its expected values will be explained and only women who provide written consents will be included in the study. three hundred women will be divided into 2 equal groups using computer generated random numbers: group 1 will have tubal flushing with hsg using water soluble media and group 2 will be the control group receiving no intervention. women undergoing hsg will be given 50 mg of diclofenac (voltaren® novartis) 1 hour before the procedure. the hsg will be performed in the same room, on the same table and with the same technique to maintain consistency and limit confounding variables. the hsg procedure will performed in a lithotomy position. a sterile metal speculum was used to visualize the uterine cervix. antiseptic solution will be used to wash the vagina and cervix. a single-toothed tenaculum will be placed on the anterior lip of the cervix. a metal cannula will be gently inserted into the external cervical os, the cannula and tenaculum will be secured together, and the speculum will be removed. gentle traction will be placed on the tenaculum, and 15 ml to 20 ml of water-soluble media (sodium amidotrizoate; urografin®, bayer, germany) will be instilled slowly via the cannula to prevent pain while the necessary images were obtained. after the procedure, the instruments will be removed and the patient will be observed for 30 minutes. women will be followed up monthly for up to 1 year.

Eligibility criteria:
inclusion criteria: * infertility for one year * normal semen analysis * normal ovulation exclusion criteria: * allergy to iodine * metformin therapy * tubal block
living conditions after non-hodgkin's lymphoma in france

Conditions: Non-hodgkin's Lymphoma

Summary: this is an innovative project, allowing to study for the first time the long-term living conditions of patients after diffuse large b-cell lymphoma (dlbcl) or follicular lymphoma (fl) from population data in france. patients will be selected from the three specialized hematology registries in france: côte-d'or, gironde and basse-normandie. this is also one of the first studies to look at epidemiological indicators of net survival after diagnosis of follicular lymphoma and diffuse large b-cell lymphoma, adjusted for clinical factors such as disease stage, therapeutic management, and comorbidities, apart from the standard adjustment factors of age, sex, and time of diagnosis in real life. in addition, the proportion of cured patients will be estimated. for component 1, this will be the survival analysis on the initial data. for part 2, questionnaires will be sent out followed by a follow-up if necessary one month after the mailing. there is no physical interview nor any specific biological or imaging examination.


Eligibility criteria:
inclusion criteria: * diagnosis period 2010-2018, according to the 2008 who icd-o-3 classification, from the hematological malignancy registries of côte-d'or, gironde, basse-normandie * patients with a diagnosis of follicular lymphoma (9690/3, 9691/3, 9695/3, 9698/3, 9597/3) * patients with a diagnosis of diffuse large b-cell lymphoma (9678/3, 9679/3, 9680/3, 9684/3, 9688/3, 9712/3, 9735/3, 9737/3, 9738/3) * for part 2: individuals alive at the date of vital status update non-inclusion criteria: * other forms of malignant hemopathies at diagnosis, * minors. exclusion criteria: * person under a legal protection measure (curatorship, guardianship) * person under a legal protection measure (guardianship, tutorship) * pregnant, parturient or breastfeeding women * major incapable or unable to express his consent * person who did not return the questionnaires following the 1-month follow-up, or patient who expressed refusal to participate.
evaluating erythropoietin as an indicator for possible kidney injury after cardiac surgery

Conditions: Erythropoietin; Acute Kidney Injury; Renal Biomarker

Summary: the purpose of the study is to evaluate kidney biomarkers and determine if there is a correlation between erythropoietin (epo) levels and acute kidney injury after cardiac surgery. an early biomarker for kidney injury may be helpful in identifying, monitoring and managing patients at risk for kidney failure after cardiac surgery. to evaluate erythropoietin's role as a predictor of poor renal function in the immediate post-bypass period we plan to compare epo levels to neutrophil gelatinase-associated lipocalin (ngal).

acute kidney injury (aki) is a serious complication after cardiac surgery and cardio-pulmonary bypass. aki is associated with high mortality. erythropoietin, a hormone produced by the kidneys, will be evaluated as a potential biomarker of kidney injury. neutrophil gelatinase-associated lipocalin (ngal) has been studied as a biomarker of kidney injury. early kidney injury detection has been long sought and ngal has been shown to be a promising biomarker. a troponinlike biomarker of aki that is easily measured and capable of both early detection and risk stratification would represent an advancement in our ability to differentiate acute kidney injury from failure. investigating epo as a biomarker may prove to have increased predictive value in the clinical care of cardiac surgery patients.

Eligibility criteria:
inclusion criteria: * cardiac surgery with cardiopulmonary bypass with dhca * normal renal function or renal insufficiency-serum creatinine less than 2.5 mg/dl * adult male and female patients 18 years and older exclusion criteria: * vads * emergent cases * prolonged hypoxemia before, during or after bypass * end stage renal disease * patients receive erythropoietin receptor agonists

Keywords: erythropoietin cardiac surgery renal biomarker acute kidney injury hypothermic circulatory arrest
protein supplementation and exercise training in burn patients

Conditions: Burns

Summary: burn injury causes continuous catabolism of the skeletal muscle resulting in decreased muscle strength, muscle mass and impairment of functional mobility. purpose: the purpose of this study is to investigate the efficacy of combination of exercise training and protein supplementation on lean body mass (lbm) and muscle strength in patients with severe burn.

sixty participants with severe burn \> 30% total body surface area (tbsa) were randomly distributed into 4 equal groups of 15 participants per group. group a (protein+ exercise group) received oral protein supplementation, exercise program and traditional burn care, group b (protein group) received oral protein supplementation and traditional burn care, group c (exercise group) received exercise program and traditional burn care, group d (control group) received traditional burn care. lbm was measured using dual-energy x-ray absorptiometry (dxa) while muscle strength was measured using biodex 3 dynamometer system before treatment and 12 weeks after treatment.

Eligibility criteria:
inclusion criteria: * healed deep partial-thickness thermal burn * \> 30% of tbsa and * the exercise program started after healing of the burn (after burn injury by 6 weeks) exclusion criteria: * conditions that may affect on participation in the exercise program as a recent coronary disease, uncontrolled hypertension, orthopedic problems limiting exercise, abnormal cardiac stress test, pregnant women, refusal to participate in a physical activity program, * presence of psychological or cognitive disorders (aggressive behavior, impulsivity, dementia) * food intolerance to milk protein products.

Keywords: exercise training protein supplementation muscle strength lean body mass burn
effect and efficacy of onyx™, zotarolimus-eluting stent for coronary atherosclerosis

Conditions: Coronary Artery Disease; Acute Coronary Syndrome; Myocardial Infarction; Angina Pectoris

Summary: the objectives of this study are 1. to establish a prospective registry of the whole patients who received percutaneous coronary intervention with resolute onyx™ stent. 2. to evaluate the long-term efficacy and safety of coronary stenting with the resolute onyx™ stent. 3. to compare the long-term efficacy and safety of coronary stenting between the resolute onyx™ stent and other contemporary drug-eluting stents which had established their own registry.

secondary endpoints are 1. stent thrombosis-24 hours(acute), 30 days(subacute), 1 year(late), every 1 year till 3 years(very-late) after index pci (percutaneous coronary intervention), 2. target vessel failure 3. composite rate of cardiac death and any mi, 3 years 4. composite rate of all death and any mi 5. composite rate of all death, any mi, and any repeat revascularization 6. compliance and therapy interruptions with prescribed adjunctive antiplatelet therapy 7. clinical device and procedural success

Eligibility criteria:
inclusion criteria: * age above 19 * patients who received pci with resolute onyx™ stent(s) exclusion criteria: * none

Keywords: coronary artery disease percutaneous coronary intervention zotarolimus-eluting stents
a study of mk0594 in patients with alcohol dependence (0594-020)

Conditions: Alcohol Dependence

Summary: a study in patients with alcohol dependence to see if mk0594 is safe and effective in maintaining absence of heavy drinking over a 12-week treatment period.


Eligibility criteria:
inclusion criteria: * patient has diagnostic and statistical manual of mental disorders, fourth edition, text revision diagnosis of alcohol dependence and alcohol addiction * patient has two heavy drinking days in the last 30 days * patient has 3 days of abstinence from alcohol right before taking study medication * patient has lived in the same residence for the last 2 months exclusion criteria: * if female, patient is pregnant or breastfeeding * patient anticipated inpatient alcohol treatment * patient has a history of suicide attempt in the last year * patient has schizophrenia or bipolar disorder * patient has a history of multiple or serious allergies * patient has participated in a clinical trial in the last 30 days